Monday, April 14, 2014

UPDATED: GSK's UK Seretide Promotion

Tonight BBC Panorama exposes yet more allegations of bribery from British pharmaceutical company GlaxoSmithKline. The program, which airs on BBC One at 8.30pm, will reveal new evidence that GSK was recently paying doctors to boost prescriptions of their asthma drug Seretide in Poland.

Hmmm...

Why go as far as Poland?

The Prescription Medicines Code of Practice Authority (PMCPA) is the self-regulatory body which administers the Association of the British Pharmaceutical Industry’s (ABPI) Code of Practice for the Pharmaceutical Industry at arm’s length of the ABPI.

Trawling through the number of case reports on their website we can see that GlaxoSmithKline were, in 2012, being investigated due to allegations made by one of its employees regarding the promotion of, and/or staff training on, Revolade (eltrombopag), Seretide (fluticasone/salmeterol) and ReQuip XL (ropinirole).

This wasn't in Poland folks... it was in the UK.

This from the alleged breaches...

The complainant alleged that the hospital business manager’s team falsified a Seretide product certification examination. All of the managers sat the product knowledge test at the same time and the answers were read out by a team member as instructed by a manager. This deliberate action, following limited training, meant that the hospital business managers were not adequately trained on Seretide when they engaged with customers. The complainant subsequently provided additional material in support of this allegation.

The complainant alleged that it was not a bona fide training event and the answers were read out to participants. GlaxoSmithKline explained that it was a knowledge consolidation event rather than evaluation, at the end of an online product training course. The Panel noted that, according to the unsigned witness statements provided by GlaxoSmithKline, whilst at least one participant completed the test alone, the majority appeared to have completed the informal test collaboratively, with the benefit of discussion.

The Panel noted GlaxoSmithKline’s submission that when HHBMs had discussions with payer customers to support specific brands, they underwent product training. The Panel noted GlaxoSmithKline’s submission that in 2011 HHBMs received 20 days of training of which 13 were product training which GlaxoSmithKline considered provided them with knowledge above and beyond that required by their role. The Panel noted that the HHBM training for Seretide in 2011 comprised product training on two separate days (neither were full days). In addition, the HHBM team did distance learning for Seretide and brand managers delivered updates at HHBM team meetings. The Panel noted GlaxoSmithKline’s submission about the need for further training to enable HHBMs to have more detailed discussions. The Panel noted that GlaxoSmithKline had, in effect, acknowledged the need for further training on Seretide. The Panel noted that the complainant bore the burden of proof. The Panel had some concerns about the HHBM Seretide training but did not consider that the complainant had demonstrated on the balance of probabilities that the product training was inadequate given the nature of calls likely to be made; no breach of the Code was ruled.